Fexuclue for Prevention of NSAIDs-Induced Peptic Ulcer in Real-World Practice
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorDaewoong Pharmaceutical Co. LTD.
About this trial
This study is a prospective, multi-center, observational study to evaluate the efficacy and safety of Fexuclue Tablet 20 mg in patients requiring prevention of NSAIDs-induced peptic ulcer in real-world clinical practice in Korea.
Patients receiving NSAIDs and requiring gastroprotective therapy will be enrolled and followed prospectively. The study will assess patient-reported outcomes (PROs) related to gastrointestinal symptoms, as well as safety outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥19 years
Patients requiring NSAIDs therapy
Patients requiring prevention of NSAIDs-induced peptic ulcer
Patients prescribed Fexuclue Tablet 20 mg
Disqualifiers
Hypersensitivity to Fexuclue or its components
Severe hepatic impairment
Pregnant or breastfeeding women
Patients considered inappropriate by investigator
Trial population
This study will enroll adult patients aged 19 years or older who require prevention of NSAIDs-induced peptic ulcer in routine clinical practice in Korea. Eligible patients are those who are prescribed Fexuclue Tablet 20 mg based on the physician's clinical judgment. Patients receiving NSAIDs and requiring gastroprotective therapy will be prospectively enrolled from multiple centers under real-world conditions. Treatment decisions will be made according to routine clinical practice. Patients with contraindications to the study drug or those deemed inappropriate by the investigator will be excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
7,000 Participants
are grouped into 1 trial groupGroup A: Fexuclue Treatment Group
Trial outcomes
Primary outcomes
1
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 2
Peptic ulcer symptoms will be assessed using a study-specific patient-reported outcome (PRO) questionnaire consisting of 6 symptom items. Each symptom is scored on a scale from 0 (none) to 4 (very severe). Symptom occurrence is defined as: Increase of ≥1 point in at least one symptom item compared to baseline Includes: New occurrence in asymptomatic patients Worsening in symptomatic patients The proportion (%) of patients with symptom occurrence at Week 2 will be calculated.
Time frame
Week 2Secondary outcomes
1
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 4
Peptic ulcer symptom occurrence is defined using the same criteria as the primary endpoint (≥1-point increase in at least one symptom item from baseline). The proportion (%) of patients with symptom occurrence will be calculated at Week 4
Time frame
Week 42
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 8
Peptic ulcer symptom occurrence is defined using the same criteria as the primary endpoint (≥1-point increase in at least one symptom item from baseline). The proportion (%) of patients with symptom occurrence will be calculated at Week 8
Time frame
Week 83
Proportion of Patients with Peptic Ulcer Symptom Occurrence at Week 12
Peptic ulcer symptom occurrence is defined using the same criteria as the primary endpoint (≥1-point increase in at least one symptom item from baseline). The proportion (%) of patients with symptom occurrence will be calculated at Week 12
Time frame
Week 124
Change From Baseline in Total Score of Patient-Reported Gastrointestinal Symptom Questionnaire at Week 2
Gastrointestinal symptoms will be assessed using a study-specific PRO questionnaire with 6 symptom items, each scored from 0 (none) to 4 (very severe). The total score ranges from 0 to 24, with higher scores indicating more severe symptoms. The outcome measure is defined as the change from baseline in total score at each time point.
Time frame
Week 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: